(51 days)
The NBD Head Screws are an accessory that is intended to support the head frame in stereotactic procedures. The head frames are supported by either a three point-of-contact or four point-of-contact position depending on the frame design.
The NBD Head Screw is a single-use threaded clear anodized aluminum screw which is manufactured in lengths ranging from 33mm-57mm.
The provided 510(k) summary for the NBD Head Screw does not contain information about acceptance criteria or a study performed to prove the device meets such criteria.
The document states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for this device." This indicates that there were no specific performance metrics or thresholds established for this device by regulatory bodies at the time of submission.
Instead of performance studies, the clearance for the NBD Head Screw was based on substantial equivalence to legally marketed predicate devices. This means the manufacturer demonstrated that their device is as safe and effective as existing, legally marketed devices with similar intended use, materials, and design, rather than through meeting specific performance metrics via a new study.
Therefore, the requested information cannot be extracted from the provided text.
Here's why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The submission states there are no applicable performance standards.
- Sample size used for the test set and the data provenance: No test set or performance study is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical accessory, not an AI or imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical accessory, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as this is not an algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).